MSD

Associate Director, Regulatory Affairs

MSD

full-time

Posted on:

Location Type: Hybrid

Location: San Jose • 🇺🇸 United States

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Job Level

SeniorLead

Tech Stack

Vault

About the role

  • Support the BSO for the Veeva Vault RIM Submissions Archive, providing support to system development, maintenance, enhancements, and monitoring.
  • Liaise with IT, Learning & Development, and global stakeholders to define and implement user requirements, workflows, and metadata standards.
  • Ensure compliance with global regulatory standards and internal SOPs for electronic submissions and correspondence.
  • Collaborate with publishing, registration, and planning teams to maintain alignment across the regulatory lifecycle.
  • Oversee the central archive team, including offshore contractors and temporary onshore staff.
  • Manage archival activities related to acquisitions, divestitures, audits, litigation, and regulatory inquiries.
  • Ensure accuracy, throughput, and quality of archival work, including budget oversight for temporary staffing.
  • Coordinate with Business Development Execution teams and system owners of related platforms (e.g., eTMF) for migration and record alignment.
  • Support GRACS’ long-term strategy to unify regulatory platforms under Veeva RIM, ensuring cross-functional coordination and system interoperability.
  • Represent the archive function in strategic planning meetings, system integration workshops, and change management initiatives.
  • Advocate for continuous improvement in archival processes, leveraging analytics and stakeholder feedback.

Requirements

  • Bachelor’s degree in a business, scientific, or operational discipline relevant to the life sciences and/or operations areas or a minimum of 12+ years of industry experience, at least 6 of those in a regulatory/compliance industry utilizing records/document management systems.
  • Direct experience in Veeva RIM Submissions Archive.
  • Proven leadership in managing both digital systems and physical archives.
  • Strong understanding of regulatory submission types (eCTD, IND, NDA, ANDA) and Health Authority requirements.
  • Knowledge of system development lifecycle, data/content administration concepts, and capabilities applying technology within a business environment.
  • Experience supporting and working with tools and systems used in a regulatory/compliance environment, including managing archival collection or distribution for acquisitions, divestitures, litigations, audits, regulatory inquiries, and ad hoc work.
  • Deep knowledge of managing records related to submissions content, health authority correspondences, and other regulatory documents.
  • Demonstrated capabilities managing and mentoring staff, including managing onshore and offshore vendors for records management and related activities.
  • Proven leadership in Change Management with an ability to lead and influence others outside of a direct reporting relationship.
  • Demonstrated collaborative skills and ability to work in cross-functional and international environments.
  • Excellent communication, stakeholder engagement, and project management skills.
  • Advanced English skills.
Benefits
  • Flexible Work Arrangements

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Veeva RIM Submissions Archiveregulatory submission typeseCTDINDNDAANDAsystem development lifecyclerecords/document management systemsdata/content administrationarchival collection management
Soft skills
leadershipcollaborationstakeholder engagementproject managementmentoringchange managementcommunicationcross-functional teamworkinfluencecontinuous improvement